Clinical Research Associate

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Perform site monitoring duties for clinical trials.

• Provide oversight, leadership, and direction in the management and execution of clinical trials.

• Ensure adherence to protocols and maintain quality standards.

• Review monitoring visit reports and carry out co-monitoring and evaluation visits as necessary.

• Ensure prompt investigator site visits are conducted.

• Collaborate with various departments to address clinical trial monitoring challenges.

• Assist in the creation of study-specific Monitoring Plans and training presentations.

• Aid in the collection of ethics documents and negotiation of site contracts.

• Supply monthly billing information to the Finance department.

• Oversee study budgets and act as the sponsor representative for independent projects.

• Conduct qualification, initiation, interim, and close-out visits both remotely and onsite.

• Prepare monitoring visit reports detailing site issues, resolutions, protocol deviations, study progress, and enrollment figures.

• Review and verify source documents and CRF data.

• Execute quality control and verification of eTMF/TMF documents.

• Manage accountability for investigational products.

• Review site regulatory binders.

• Maintain communication with study sites regarding protocol/GCP compliance, accrual, and sponsor requests.

• Ensure compliance with ICH GCP, FDA regulations, and standard operating procedures (SOPs).

• Facilitate the reporting of adverse events and reconcile SAE reports with source documentation and CRFs.

• Resolve discrepancies in data queries with in-house CRAs/CTC and Data Management.

• Identify site-related issues and formulate problem-solving strategies.

• Prepare for audits at study sites.

• Assist in the training and onboarding of CRAs; provide mentorship to CRAs.

• Collaborate on the development and maintenance of Clinical Trial Management Systems (CTMS).

• Manage conflicting priorities effectively and fulfill commitments.

⛳️ Requirements

• Minimum of 2 years of monitoring experience.

• Ability to establish and sustain positive relationships with Sponsors, Site, and Project Team members.

• Capability to independently manage monitoring activities.

• Quality-focused; demonstrated ability to be meticulous, thorough, and detail-oriented.

• Strong organizational abilities and the capacity to multitask and work efficiently in a dynamic environment.

• Proficient in managing priorities, organizing time, and solving problems.

• Strong analytical, negotiation, meeting management, cross-functional team collaboration, and leadership skills.

• Willingness to travel.

• Ability to handle stress effectively.

• Professional, reliable, and disciplined.

• Capacity to address unstructured or ambiguous challenges through problem-solving.

• Strong command of the local language, both written and verbal, in the region where monitoring activities are conducted.

• Excellent communication and interpersonal skills, with a strong customer service orientation.

• Proficient computer skills, including knowledge of clinical trial management systems, clinical trial databases, and electronic data capture.

• Understanding of clinical research, ICH GCP, and local regulations.

• Familiarity with regulatory and ethical requirements.

• Bachelor's degree in Biology, Life Sciences, or a related field of study.

🏝️ Benefits

• Opportunity for professional growth and development.

• Access to a collaborative and supportive work environment.

• Competitive compensation and benefits package.